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ObesityNCT04974450

Trigona Honey and Intestinal Microbiota Among Obese People

A study testing Trigona honey in people with Obesity, run by Hasanuddin University at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective : Nutrition intervention is one of the approaches to deal with obesity. Natural honey with its polyphenol component has an impact on the intestinal microbiota and lipid profile. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Trigona honey
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndonesia
Study dates
1 Jun 2021to 1 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Defined as obese with a body mass index of more than 27
  • Not having a gastrointestinal disease
  • Not allergic to the honey component

Who cannot join

  • Consuming probiotics for a minimum of one month
  • Consuming antibiotics for a minimum of one month

Trial locations and contacts

1 site in 1 country.

Andi S Rahma, MD contact

+6285242714698

andisittirahma@yahoo.co.id

Indonesia1 site, 1 recruiting

  • Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi, 76124

    Andi S Rahma, MD, +625242714698, andisittirahma@yahoo.co.id

    Andi S Rahma, MD

    Recruiting

Other trials in Indonesia

About this study

Official title: Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals

Objective :

Nutrition intervention is one of the approaches to deal with obesity. Natural honey with its polyphenol component has an impact on the intestinal microbiota and lipid profile. Intestinal microbiota such as lactobacillus and bifidobacteria produce exopolysaccharide which plays important roles against obesity. This research aims to assess the effect of Trigona biroi honey on body mass index, lipid profile, and microbiota profile

Read more

Design A Quasi-experimental study involving two arms (trigona honey) and control will be conducted. The outcome of interests are body mass index, lipid profile, and microbiota profile

Hypothesis using superiority trial, trigona honey will

  1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium)
  2. Improving lipid profile
  3. lowering body mass index
Read the detailed description

Target population :

This study will recruit healthy participants with a body mass index of more than 27

allocation : non-random with propensity score matching

Arms

  1. Trigona honey (intervention) composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile
  2. Active comparator Commercial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

Intervention 8 weeks, once daily. This also applied to the control group

Outcome :

  1. Microbiota detected using Polymerase Chain Reaction (PCR)
  2. Sample: Stool
  3. extraction with 70% ethanol primary PCR
  4. primer (Lactobacillus and bifidobacteria)
  5. Lipid Profile using blood plasma and homogenous assay High-Density Lipoprotein, Low-Density Lipoprotein, Triglyceride, total cholesterol
  6. Anthropometry Body mass index, body composition (fat percentage), waist circumference

Sample Size was calculated using the difference of HDL between groups with the following parameters :

Effect size =0.3 Type 1 error = 5% Power of Study = 80% dropout = 20% total participant 336

Analysis Intention to treat will be applied. The descriptive statistic will be used to describe the baseline characteristic of participants. The bivariate analysis will be conducted to see the association of demographic factors to the outcome. If the matching of the participant yields a similar baseline characteristic, the difference of mean between the two groups will be analyzed using an independent t-test. Otherwise, linear mixed model will be applied

Conditions
Obesity
Being tested
Trigona honey, control
Keywords
obesity, trigona honey, lipid profile, microbiota, anthropometry
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trigona honeyDietary supplement

    composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile

  • controlDietary supplement

    Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

Study groups in NCT04974450
Study groupRoleWhat they receive
Trigona HoneyExperimentalThe intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks
Receives: Dietary Supplement: Trigona honey
ControlActive comparatorThe intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks
Receives: Dietary Supplement: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of intestinal microbiota in stool

    the level of bifidobacteria, clostridium, and lactobacillus (in colony factor unit/grams) in stool measured using polymerase chain reaction

    Measured: Changes of microbiota level from day 0 to day 60 after intervention

Secondary outcomes (2)

  1. Body Mass Index

    measured by dividing body weight in kilogram per square meter of height

    Measured: Changes of body mass index from day 0 to day 60 after intervention

  2. Lipid Profile

    the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma

    Measured: Changes of lipid profile from day 0 to day 60 after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two different groups will be given two different honey. In the intervention group, trigona honey will be administered for 8 weeks whereas the control group will be given artificial honey that has a similar taste and appearance to the intervention group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974450
Sponsor's protocol ID
1007210708
Status last verified
Jul 2021
First submitted
14 Jul 2021
Last updated
23 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: de-identified data will be shared accordingly

Publications

  • de Melo FHC, Menezes FNDD, de Sousa JMB, Dos Santos Lima M, da Silva Campelo Borges G, de Souza EL, Magnani M. Prebiotic activity of monofloral honeys produced by stingless bees in the semi-arid region of Brazilian Northeastern toward Lactobacillus acidophilus LA-05 and Bifidobacterium lactis BB-12. Food Res Int. 2020 Feb;128:108809. doi: 10.1016/j.foodres.2019.108809. Epub 2019 Nov 21.

    PubMed 31955768

  • Jiang L, Xie M, Chen G, Qiao J, Zhang H, Zeng X. Phenolics and Carbohydrates in Buckwheat Honey Regulate the Human Intestinal Microbiota. Evid Based Complement Alternat Med. 2020 Feb 26;2020:6432942. doi: 10.1155/2020/6432942. eCollection 2020.

    PubMed 32184894

  • Lashani E, Davoodabadi A, Soltan Dallal MM. Some probiotic properties of Lactobacillus species isolated from honey and their antimicrobial activity against foodborne pathogens. Vet Res Forum. 2020 Spring;11(2):121-126. doi: 10.30466/vrf.2018.90418.2188. Epub 2020 Jun 15.

    PubMed 32782740

  • Mohd Rafie AZ, Syahir A, Wan Ahmad WAN, Mustafa MZ, Mariatulqabtiah AR. Supplementation of Stingless Bee Honey from Heterotrigona itama Improves Antiobesity Parameters in High-Fat Diet Induced Obese Rat Model. Evid Based Complement Alternat Med. 2018 Nov 21;2018:6371582. doi: 10.1155/2018/6371582. eCollection 2018.

    PubMed 30643535

  • Samat S, Kanyan Enchang F, Nor Hussein F, Wan Ismail WI. Four-Week Consumption of Malaysian Honey Reduces Excess Weight Gain and Improves Obesity-Related Parameters in High Fat Diet Induced Obese Rats. Evid Based Complement Alternat Med. 2017;2017:1342150. doi: 10.1155/2017/1342150. Epub 2017 Jan 26.

    PubMed 28246535

Questions about this trial

What is this clinical trial studying?

A study testing Trigona honey in people with Obesity, run by Hasanuddin University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andi S Rahma, MD (+6285242714698, andisittirahma@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of intestinal microbiota in stool (time frame: Changes of microbiota level from day 0 to day 60 after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974450, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

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